Transforming Clinical Data Governance Specialist

1 week ago

Hyderabad, Telangana, India beBeeDataGovernance Full time ₹ 1,20,00,000 - ₹ 2,50,00,000
Job Title: Senior Clinical Data Governance Specialist

Job Description:
As a key member of the Clinical Information Governance team, you will serve as a metadata expert and lead the governance of CDISC data standards across therapeutic areas. Your role will involve providing in-depth knowledge and guidance on clinical data standards, CDASH, SDTM, External Data, Controlled Terminology, and regulatory requirements. You will also actively lead the development of CDISC-compliant end-to-end metadata specifications for new study-specific forms.

Responsibilities:
  • Act as a Metadata Lead Expert for CDASH, SDTM, External Data, or Controlled Terminology
  • Understand the application of the CDISC models across the life cycle of a trial
  • Lead Global Study Request Review Meetings for the specific Data Standards Model of expertise
  • Provide SME expertise during the eCRF review at the study level with the Study Team and ensure study-specific metadata are aligned with the CIG Clinical Data Standards strategy

Requirements:
  • Experience in Pharmaceutical Industry with strong involvement in the clinical data flow, specialized in Data Standards Management
  • Strong knowledge of industry data standards and practices, e.g., CDISC, CDASH, SDTM
  • CDISC certification in one or more models
  • Good understanding of end-to-end clinical data flows and data structures

About Us:

We provide equal opportunities to all, regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability, or gender identity.

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